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Completed

NCT Number: NCT00348855

Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice

Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.

Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.

Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.

Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.

In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.

Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service de Pharmacologie Clinique, Lyon, France

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About this study

Cluster randomised pragmatic controlled trial in general practice

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treated High blood Pressure patients with at least two other cardiovascular risks

Exclusion criteria

  • Secondary prevention

Treatment and study plan

Cardiovascular drugs strategies

Other

Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.

Compliance

Behavioral

Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.

Exercise

Behavioral

Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.

Stop smoking

Behavioral

Minimal intervention

Diet

Behavioral

Discussion with the patient on his (her) alimentation during each of the six consultations and assessment of daily diet at inclusion, year 1 and year 2.

Feed Back

Other

Feed back on results in the intervention group at baseline, Year 1 ans Year 2.

Primary outcomes

  1. Number of patients who reach all the therapeutic goals defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and T2D.

    Time frame: At inclusion, year 1 and year 2

Secondary outcomes

  1. Number of targets reached by the patients

    Time frame: At inclusion, year 1 and year 2

  2. Quality of life measured with SF8

    Time frame: At inclusion, year 1 and year 2

  3. Compliance

    Time frame: At inclusion, year 1 and year 2

  4. Exercise

    Time frame: At inclusion, year 1 and year 2

  5. Diet

    Time frame: At inclusion, year 1 and year 2

  6. Levels of blood pressure, LDL-Cholesterol, tobacco consumption in the whole population plus levels of HbA1c and aspirin use in the TD2 population

    Time frame: inclusion, year 1 and year 2

Sponsors and collaborators

Lead sponsor

Collège National des Généralistes Enseignants

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Laboratoires Takeda
  • Merck Serono International SA

Registry information

Official study title

Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk

Acronym: ESCAPE

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jul 6, 2006
Registry last updated
Nov 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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